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April 15, 2018 THE TOP 001_ro0418_fc v2.indd 1001_ro0418_fc v2.indd 1 REVIEW OF OPTOMETRY ■ VOL. 155 NO. 4 ■ APRIL 15, 2018 ■ ANNUAL PHARMACEUTICALSMMACEEUTICAALSS REPORTRREPPORTT ■ LOWLOW VISIONVISION ANDANND DRIVINGDRDRIVIIIVVVIINNGG TheraTears® is clinically proven to reduce the signs and symptoms of dry eyes1 TheraTears® Dry Eye Average Tear Osmolarity Level Therapy Lubricant Eye BASELINE 1 WEEK Drops with Osmo-Correction® • Reduced patient symptoms (OSDI) up to 33% • Restored tears to normal osmolarity levels within 322.8 305.2 ±20.3 mOsm/L ±27.7 m0sm/L one week (High Osmolarity) (Normal Osmolarity) More than eye drops, dry eye therapy™ THERAPY FOR YOUR EYES theratears.com Study sponsored by Akorn Reference: 1. Ng L, Nguyen A, Karpecki P, Houtman D. Evaluation of Tear Osmolarity Over Time with Sustained Use of TheraTears® Lubricant Eye Drops. Poster presented at: The American Academy of Optometry Annual Meeting; November 9-12, 2016; Anaheim, CA. © 2017 Akorn Consumer Health | A Division of Akorn, Inc. | M16-039 RP1017_Akorn Consumer.indd 1 9/20/17 9:55 AM News Review VOL. 155 NO. 4 ■ APRIL 15, 2018 IN THE NEWS Hope For Noninvasive Hydrogel and overnight orthokeratol- ogy (OK) contact lens (CL) wear can ICP Monitoring increase tear fi lm osmolarity, a new study fi nds. Researchers observed osmo- Ultrasonography may one day help patients avoid a larity values in non-CL wearers and those who have worn hydrogel and overnight painful lumbar puncture. OK lenses for at least three years, and By Rebecca Hepp, Managing Editor found osmolarity was within normal limits Photos: Nate Lighthizer, OD Photos: Nate Lighthizer, in all groups, although it was signifi cantly linicians have long known lower in non-CL wearers compared with intracranial pressure (ICP) hydrogel and OK lens wearers. Osmolar- Cplays a critical role in idio- ity returns to baseline one month after pathic intracranial hypertension, discontinuation of CL wear. and “there has also been debate Nieto-Bona A, Nombela-Palomo M, Felipe-Márquez about its potential role in other G, Teus MA. Tear fi lm osmolarity in response to long- term orthokeratology treatment. Eye Contact Lens. disease states such as glaucoma,” 2018;44(2):85-90. says Nate Lighthizer, OD, an Researchers found day one post-op associate professor and assistant assessment with swept-source OCT dean of Clinical Care Services at provided better visualization of the Oklahoma College of Optom- macula than spectral-domain (SD) etry. “There is current thinking OCT in patients treated with pars plana now that perhaps glaucoma is a vitrectomy and gas tamponade. For two-pressure disease: the balance patients with rhegmatogenous retinal between intraocular pressure and detachment, SD-OCT provided good intracranial pressure. So better visualization on day one in 35.3% of eyes understanding the role ICP plays compared with 73.5% of eyes using Ultrasonography can reveal any number SS-OCT’s line scan protocol. In eyes with in many disease states may be a macular holes, the rates were 59.3% critical element in the future.” of issues, such as choroidal melanoma with SD-OCT and 88.9% with SS-OCT’s Unfortunately, the standard with overlying retinal detachment, top, line scan protocol. test for diagnosing elevated ICP, and optic nerve drusen, bottom. Recently, Ahn SJ, Park SH, Lee BR. Visualization of the macula lumbar puncture (LP), is invasive reseachers found measuring optic nerve in gas-fi lled eyes: Spectral domain optical coherence and painful.1 Recently, researchers sheath diameter with ultrasonograpy tomography versus swept-source optical coherence tomography. Retina. 2018;38(3):480-9. have sought noninvasive methods may be a noninvasive method of for dynamically monitoring ICP, monitoring ICP. Clinicians should endeavor to refer and think ultrasonography may be patients with orbital-fl oor trap-door the key.1 correlation between the ONSD blowout fractures with incarcerated Researchers in China used ul- and ICP values on admission, and tissue for surgery within eight days, according to new research. The study trasonography to measure the op- a strong correlation between the found ocular motility outcomes were tic nerve sheath diameter (ONSD) change in ONSD and ICP values signifi cantly better for patients who un- in 60 patients admitted for lumbar one month later. Post-treatment, derwent repair surgery within eight days puncture. After LP, the patients the elevated ICP and dilated of injury than those after eight days. were split into two groups, ONSD had returned to normal, 1 Yamanaka Y, Watanabe A, Sotozono C, Kinoshita S. those with elevated ICP between the researchers found. Impact of surgical timing of postoperative ocular motility in orbital blowout fractures. Br J Ophthalmol. 200mm H2O and 300mm H2O Other studies have highlighted 2018;102(3):398–403. and those above 300mm H2O. ultrasonography’s utility in The investigators noted a strong (continued on page 5) REVIEW OF OPTOMETRY APRIL 15, 2018 3 003_ro0418_news.indd 3 3/30/18 4:38 PM News Review FDA Hits Opternative with Notice he Food and Drug Admin- On-Line Opternative Eye Examina- The American Optometric Asso- istration (FDA) has advised tion Mobile Medical App device, ciation (AOA) is counting the FDA’s Tonline refraction company such as the commercial distribution action as “validation” of its 2016 Opternative that its services consti- of the device through your online complaint. “Despite the October tute a medical device and, as such, website.” 2017 FDA warning letter, Opterna- require “marketing clearance,” ac- “We responded promptly to tive has continued to market their cording to a letter the agency issued FDA’s warning letter from October device through 1-800 Contacts, etc. in October, but didn’t publicize until 2017, and we are working dili- until the fi ling was made public,” March. The letter indicates that the gently to voluntarily comply with says Clarke Newman, OD, AOA company, which was sending mar- all regulatory requirements,” says Federal Relations Committee chair. keting e-mails as of March 22, has a representative from Opternative. “We recognize our technol- been operating in violation of the “We continue to communicate with ogy and our new way of helping Federal Food, Drug, and Cosmetic the FDA on a regular basis to work patients get their prescriptions Act. In the letter, the FDA “requests through the regulatory medical renewed are viewed as disruptive to that Opternative, Inc. immediately device clearance process with our those who wish to prohibit emerg- cease activities that result in the outside experts.” ing technologies from entering the misbranding or adulteration of the The FDA’s letter also says that vision prescription renewal space,” the agency determined that the app said an Opternative representative. “is a device because it is intended Although the AOA has histori- for use in the diagnosis of disease cally opposed online refraction, a or other conditions or in the cure, spokesperson underscores that the mitigation, treatment, or prevention association supports technologies, of disease, or to affect the structure so long as they don’t interrupt the or any function of the body.” It patient-doctor relationship. also outlines how Opternative can submit for premarket approval Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. Opternative Opternative just hit a roadblock with an and “whether the product may be Inc 10/30/17 Warning Letter. www.fda.gov/iceci/ FDA warning letter. legally marketed.” enforcementactions/warningletters/2017/ucm600029.htm. Clinical Acumen Boosts AI Accuracy lthough artifi cial intelligence sensus of the retina specialists as the study author Lily Peng, MD, PhD.1,2 (AI), and the machine learn- reference standard. Although reference cases are Aing algorithm that drives After adding the reference cases key to “teach” any deep learning it, shows promise as a screening “as a tuning dataset,” the inves- machine to properly screen for DR, tool for ocular pathology such as tigators looked at the area under creating those standards is time- diabetic retinopathy (DR), it’s not the curve (AUC), sensitivity and consuming. The researchers were perfect. But researchers at Google specifi city data between the manual happy to fi nd using just a small found using a small set of DR cases grading and the algorithm. With the subset of carefully adjudicated cases judged by ophthalmologists and new data, the algorithm improved could make a huge difference in the retina specialists can improve the its AUC from 0.934 to 0.986 when algorithm’s performance. algorithm’s accuracy.1 screening moderate or worse DR, a 1. Krause J, Gulshan V, Rahimy E, et al. Grader variability and The researchers had the clinicians boost that enabled the AI system to the importance of reference standards for evaluating machine and the algorithm grade retinal perform similarly to or even exceed learning models for diabetic retinopathy. Ophthalmology. March 12, 2018. [Epub ahead of print]. fundus images from DR screening US board-certifi ed ophthalmologists 2. Human adjudication of DR grading enhances machine programs and then chose the con- and retinal specialists, according to learning algorithm. Healio. March 14, 2018. 4 REVIEW OF OPTOMETRY APRIL 15, 2018 003_ro0418_news.indd 4 3/30/18 4:39 PM The doctor gave me six months… Monitoring ICP Sans LP (continued from page 3) OMG! measuring elevated ICP, and this study “adds further evidence for the sensitivity and specifi city of ul- trasonography for this purpose,” according an editor’s note from Andrew G.